Category: surgical sealant

Today at the 95th Annual Clinical Congress of the American College of Surgeons, Covidien introduced its V-Loc absorbable device for knotless, soft tissue repair.

"The V-Loc device is a breakthrough in dermal wound closure technology, and the feedback we are getting from surgeons who have tested the device is overwhelmingly enthusuastic," said Dr. Michael Tarnoff, Chief Medical Affairs Officer, Surgical Devices, at Covidien.

Products and technologies used in advanced wound management have found varying degrees of success in global markets, stemming from differences in clinical practices, cultures, sensitivities, demographics and other geographically-driven differences. At the macro view, the size of the advanced wound management market by countries falls in a typical pattern based on the relative size of the populations and healthcare markets:

The differences between these markets in their relative adoption and use of advanced wound management technologies is illustrated in the graph below, showing the percent of each country’s total market that is represented by each wound product type.

As recently as 10 years ago, the biochemical mechanisms underlying tissue repair were still incompletely understood. For example, during the early 1990s as many as a hundred companies were actively engaged in clinical trials evaluating efforts to accelerate repair based on applying higher than physiological levels of growth factor to non-healing tissue. By 2003, many companies had abandoned this approach due to disappointing results.

A better understanding of the underlying mechanisms of tissue repair has led to the evaluation of more complex approaches, combining structural repair materials with active pharmacological agents, biologically derived and cellular components. This improved knowledge of physiological healing processes has led to formulation and adoption of new securement and adjunctive surgical devices, resulting in improved hemostasis, reduction in post-surgical adhesion (PSA) formation, and stronger and quicker biological repair.

Commercial Imperatives

MedMarket Diligence carried out a review of the companies exploiting medical devices targeted at the surgical securement market to examine the products they market and the timelines associated with their approvals. A greater awareness of regulatory approval mechanisms and requirements around the world has become apparent in this market sector, and we believe this indicates a growing trend in the medical device industry overall. In the United States, a new medical device is usually marketed after the FDA approves a pre-market application (PMA) or clears a 510(k) pre-market notification submission. Through a conscious effort by the FDA, the time required for the agency to carry out this approval has been steadily reduced and is now around 3 months for a 510(k) and 13 months for a PMA. The FDA has also worked to make the approval process less arbitrary.

Regulatory bodies in Europe and Japan also have achieved significant advances in the last 10 years to streamline their approval processes so that clear guidelines are given for approval and reimbursement categories. In addition, companies making submissions have become more aware of the need to identify the key factors for approval and to engage with the regulatory bodies early in the process to clarify the routes forward for any exceptional aspects of product development.

We also found that all medical device businesses (from small biotechnology companies to large capital conglomerates) are becoming more efficient at managing their new product pipelines, and focusing on a mixture of short-term product concepts and longer-term, more risky breakthrough opportunities.

LifeBond of Israel is developing, and seeking FDA and European approval for marketing in 2010, protein-based surgical sealants that the company claims provide greater adhesive strength than blood-derived fibrin sealants. The LifeBond products, formulated in the LifeSeal SLR staple line reinforcement sealant and the LifeSeal Surgery sealant are crosslinked gelatin that are applied as an adhesive hydrogel matrix.

A key aspect to take note of in the LifeBond products is that they are protein-based and provide adhesive strength that is competitive with fibrin and other blood-based sealants. This is crucial because on blood-based sealants allow for internal use, while cyanoacrylate-based medical glues (like Ethicon’s Dermabond) provide greater adhesive strength, but are prohibited from internal use due the toxicity of cyanoacrylate and its by-products.

“LifeBond was established in Israel in 2007 to develop sealants and active hemostats that incorporate a proprietary adhesive formulation that mimics the biochemical cross-linking cascade of late-stage blood coagulation. The sealant forms a network similar to the fibrin network of blood clots but has demonstrated adhesive strength the company claims is greater than that of blood-derived fibrin sealants. The LifeBond adhesive comes in gelatin-based hemostat form (LifePatch Surgery and LifePatch Heavy absorbable hemostats) and LifeSeal GI (gastrointestinal) and LifeSeal (general surgery) sealants.”

The tissue closure and securement market can be regarded as a benchmark indicator for overall expansion of medical device usage. This is because surgical closure and securement products are growing to be components of all surgical procedures. These products are used for rapid and efficient closure of surgical wounds, and internal securement of tissues to reduce pain and accelerate rehabilitation. Appropriate use of these products can reduce risk of infection, and can optimize the repair process to enhance the speed and strength of tissue repair, as well as reducing complications such as those resulting from post-surgical adhesions. Below are definitions for the products in the field of surgical closure and securement.

Definition of Surgical Closure and Securement Products

Suture

Sutures are medical devices made out of woven or single filament fibers of steel, synthetic polymer or natural biomaterials that are used to secure cuts, lacerations, and incisions in the surface or internal tissues.

Staple

Staples are rigid or semi-rigid suture-like materials delivered through a closure device and consisting of single- or multi-filament fibers of steel, synthetic polymer or natural biomaterials that are used to secure cuts, lacerations, and incisions in the surface or internal tissues.

Tape

Tapes are fabric and polymer-based medical devices that are used to secure cuts, lacerations, and incisions in the surface of the skin as an adjunct to wound closure.

Hemostat

A hemostat reacts in the presence of blood to establish the normal cascade of factors that arrest bleeding. These products can be added to a bleeding field during surgery to prevent further bleeding, and are mostly dependent on a full complement of normal factors in the patient’s blood.

Sealant

A sealant will prevent leakage of fluid and/or gas from a surgical incision (such as pulmonary gases or spinal fluids). These products will often hold back pressurized fluids from normal vascular activity. Although their efficiency does not normally require the full complement of active clotting factors in blood to be within normal levels, these products (e.g., fibrin sealants) normally also have some hemostatic activity.

Glue/adhesive

Glues and adhesives (e.g., cyanoacrylate glues) are used to attach organs, structures, or tissues to each other or to effect repair. These materials can be enhanced by incorporating additional hemostatic or sealant properties, such as Angiotech’s Vitagel (a combination of collagen and thrombin) and Nycomed’s Tachocomb (a combination of thrombin, collagen and fibrin).

Adhesion

Abnormal joining of two organs or tissues occurring after inflammation, especially post-surgery. Adhesion-prevention products are medical devices or substances made from synthetic polymer or natural biomaterials that are manufactured into gels, fabrics, films, and dried solids that are used to avoid the formation of post-surgical adhesions (PSA).